Heart valve support device

Abstract

Devices for assisting with the functioning of a tricuspid valve of a heart include a shaft, a flow optimizer, and an anchoring mechanism. A tilting mechanism can be configured to tilt the shaft relative to a central axis of the anchoring mechanism. Leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and a rim, and the rim can have a higher stiffness than the membrane.

What is claimed is: 
     
       1. A device for assisting with functioning of a cardiac valve of a heart, comprising:
 a shaft; 
 a flow optimizer fixedly connected to a distal end region of the shaft; 
 an anchoring mechanism comprising a core having a socket therein; and 
 a rotation element positioned within the socket, the rotation element having a lumen therein through which the shaft is configured to extend, wherein the rotation element is configured to move within the socket so as to tilt the shaft relative to the anchoring mechanism. 
 
     
     
       2. The device of  claim 1 , wherein the anchoring mechanism further comprises a plurality of anchoring arms extending radially away from the core. 
     
     
       3. The device of  claim 1 , wherein the shaft is configured to slide axially and rotate within the lumen. 
     
     
       4. The device of  claim 1 , wherein the core comprises an angled ledge configured to limit a tilt angle of the flow optimizer relative to the anchoring mechanism. 
     
     
       5. The device of  claim 4 , wherein the angle is less than 45 degrees. 
     
     
       6. The device of  claim 1 , further comprising a locking mechanism configured to lock an angle of tilt of the flow optimizer relative to the anchoring mechanism. 
     
     
       7. The device of  claim 6 , wherein the locking mechanism is further configured to lock an axial and rotational position of the flow optimizer relative to the anchoring mechanism. 
     
     
       8. The device of  claim 6 , wherein the locking mechanism comprises one or more screws configured to extend through the core and engage the rotation element. 
     
     
       9. The device of  claim 6 , wherein the locking mechanism comprises an annular lock configured to fit between the rotation element and the rotation element. 
     
     
       10. The device of  claim 9 , wherein the annular lock is configured to move axially between a proximal position in which the rotation element is configured to rotate and a distal position in which the rotation element is fixed. 
     
     
       11. The device of  claim 9 , wherein the annular lock is a snap fit lock. 
     
     
       12. The device of  claim 9 , wherein the annular lock includes threaded grooves configured to mate with threaded grooves on an inner surface of the core. 
     
     
       13. The device of  claim 1 , wherein the flow optimizer comprises a frame and a plurality of leaflets attached to the frame. 
     
     
       14. The device of  claim 13 , wherein the plurality of leaflets are configured to expand to an expanded configuration during systole to block a flow of blood around the flow optimizer and to collapse to a collapsed configuration during diastole to allow a flow of blood around the flow optimizer. 
     
     
       15. A method of assisting with functioning of a cardiac valve, comprising:
 inserting a cardiac valve device into a native cardiac valve, wherein the cardiac valve device comprises a shaft, a flow optimizer, and an anchoring mechanism; 
 fixing the anchoring mechanism at commissures leaflets of the native cardiac valve; and 
 tilting the shaft relative to a central axis of the anchoring mechanism so as to position the flow optimizer at a desired angular positon within the native cardiac valve. 
 
     
     
       16. The method of  claim 15 , wherein tilting the shaft comprises rotating a ball within a socket of the cardiac valve device. 
     
     
       17. The method of  claim 15 , further comprising:
 during diastole, reducing a cross-sectional area of the flow optimizer to allow hemodynamic flow around and through the flow optimizer; and 
 during systole, increasing a cross-sectional area of the flow optimizer to seal an orifice of the native cardiac valve. 
 
     
     
       18. The method of  claim 15 , further comprising axially moving the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired axial position within the native cardiac valve. 
     
     
       19. The method of  claim 15 , further comprising rotating the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired rotational position within the native cardiac valve. 
     
     
       20. The method of  claim 15 , further comprising locking the flow optimizer at the desired angular position with a locking mechanism. 
     
     
       21. The method of  claim 20 , wherein the locking mechanism further locks an axial and rotational position of the flow optimizer relative to the anchoring mechanism. 
     
     
       22. The method of  claim 20 , wherein the locking mechanism comprises one or more screws. 
     
     
       23. The method of  claim 20 , wherein the locking mechanism comprises an annular lock configured to fit around the shaft. 
     
     
       24. The method of  claim 23 , wherein locking comprises distally moving the annular lock relative to the anchoring mechanism. 
     
     
       25. The method of  claim 23 , wherein locking comprises rotating the annular lock relative to the anchoring mechanism.